A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

September 5, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Arizona
      • Glendale, Arizona, United States
      • Tempe, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Paragould, Arkansas, United States
      • Pine Bluff, Arkansas, United States
    • California
      • Fountain Valley, California, United States
      • La Mesa, California, United States
      • Long Beach, California, United States
      • Lynwood, California, United States
      • Orange, California, United States
      • San Diego, California, United States
      • Whittier, California, United States
    • Florida
      • Brandon, Florida, United States
      • Hudson, Florida, United States
      • Lauderdale Lakes, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Evanston, Illinois, United States
      • Evergreen Park, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • New Jersey
      • Eatontown, New Jersey, United States
    • New York
      • Flushing, New York, United States
      • Springfield Gardens, New York, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Lewistown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Sumter, South Carolina, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Alexandria, Virginia, United States
      • Portsmouth, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • West Allis, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, and is >=18 years old
  • Stable hemodialysis or peritoneal dialysis
  • Subjects has Stable phosphate control
  • Subjects on Stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • Female and of child-bearing potential have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

  • Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • serum albumin level < 3.0g/dL
  • PTH level > 1000pg/mL
  • Hemoglobin level < 8mg/dL
  • A History of significant gastrointestinal motility problems
  • Biliary obstruction or proven liver dysfunction
  • A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
  • A clinically significant severe lactose intolerance or sensitivity
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • using cholestyramine, colestipol or colesevelam
  • Schedule to receive a kidney transplant within the next 6 months
  • Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®
Placebo Comparator: 2
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Serum Phosphorus From Week 12 to Week 16
Time Frame: 4 weeks (Week 12 to Week 16)
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
4 weeks (Week 12 to Week 16)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Phosphorus
Time Frame: 12 weeks (Week 0 to Week 12)
12 weeks (Week 0 to Week 12)
Change From Baseline in PTH
Time Frame: 12 weeks
12 weeks
Change From Baseline in Calcium
Time Frame: 12 weeks
12 weeks
Change From Baseline in Calcium x Phosphorus Ion Product
Time Frame: 12 weeks
12 weeks
Change From Baseline in Total Cholesterol
Time Frame: 12 weeks
12 weeks
Change From Baseline in LDL Cholesterol
Time Frame: 12 weeks
12 weeks
Change From Baseline in HDL Cholesterol
Time Frame: 12 weeks
12 weeks
Change From Baseline in VLDL Cholesterol
Time Frame: 12 weeks
12 weeks
Change From Baseline in Triglyceride
Time Frame: 12 weeks
12 weeks
Incidence of Adverse Events
Time Frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
12 weeks (Week 0-12) and 4 weeks (Week 12-16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Principal Investigator: Professor, Information at Mitsubishi Pharma America

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI-196-A05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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